1. Field of Invention
This invention relates to the production of comestibles. More specifically it is concerned with a candy product which is rendered anticariogenic through the use of a novel cariostatic additive.
2. Description of the Prior Art
The prior art has long sought a means to compensate for the cariogenic potential of comestibles, particularly foods containing high preponderances of sweeteners such as sucrose and other sugars. It has been theorized that, when sugars are placed in the mouth, they give rise to the production of acids which promote dental caries.
A contributing cause of dental caries in children is the adherence of highly refined sugars and their decomposition products to the dental plaque after ingestion, coupled with the slow rate of oral clearance, or the ability to produce high amounts of acid, or combinations of such factors.
A number of cariostatic agents have been evaluated in the past in systems wherein the agent is applied or consumed topically (i.e., directly on the teeth) in the form of a dentifrice (e.g., a toothpaste or a toothpowder). However, knowledge gained on the effectiveness of cariostatic agents used in such topical applications has not permitted prediction of efficacy for these cariostatic agents in other applications, such as in foods, and particularly in foods containing a substantial portion of sugars.
Unfortunately, known cariostatic agents have in general not provided any substantial degree of protection when used in foodstuffs. Thus, known cariostatic agents such as fluorides, phosphates, vitamin K, nitrofurans, ammonium compounds, iodoacetic acid and the like, when added separately to a food stuff containing a high percentage of sugar, have little direct topical effect in a foodstuff environment.
For the foregoing and other reasons, dental researchers have continued their efforts to develop new anticariogenic agents which not only demonstrate a high level of anticariogenic effectiveness but which are non-toxic, stable, and widely available. It has been suggested that aluminum salts may have a beneficial effect in reducing dental caries or in facilitating the uptake of fluoride by the dental enamel. See, e.g., Manly et al., "Substances Capable of Decreasing the Acid Solubility of Tooth Enamel," J. Dent Res. 28: 160 (1948); Regolati, et al., "Effects of Aluminum and Fluoride on Caries, Fluorine Content and Dissolution of Rat Molars," Hel. Odon. Acta. 13: 59 (1969); and Kelada, "Electrochemical Characteristics of Free and Complexed Fluorides in Drinking Water and The Effects of Aluminum and Iron on Fluoride Incorporation Into Tooth Enamel," Univ. Michigan Thesis (1972).
In vitro studies have shown that pretreatment of enamel with aluminum solutions resulted in increased fluoride uptake when followed by treatment with a fluoride solution; however, treatment with combinations of aluminum and fluoride did not afford any added benefit over that of fluoride alone. McCann, "the Effect of Fluoride Complex Formation on Fluoride Uptake and Retention in Human Enamel," Archs. Oral Biol. 14:521 (1969); and Gerhardt, et al., "Fluoride Uptake in Natural Tooth Surfaces Pretreated with Aluminum Nitrate," J. Dent. Res. 51:870 (1972). Moreover, the foregoing techniques have dealt primarily with the use of aluminum in combination with fluorides and have not focussed on the effect of aluminum in the absence of fluoride.
It has heretofore been suggested that the addition of a source of aluminum to the diet may reduce the cariogenic potential thereof. However, studies have to date suggested that aluminum is ineffective as a dietary anticariogenic agent. Thus, Van Reen, et al., "Trace Elements and Dental Caries: Molybdenum, Aluminum, and Titanium," Helv. Odont. Acta., 11:53-59 (1967), concluded (p. 57) that "Aluminum potassium sulfate when added to the drinking water of rats to provide 10, 50, or 100 ppm of aluminum did not afford any protection against dental caries . . . ." The same conclusion was reached with aluminum added to the dietary ration fed rats, as reported by Wynn et al., "Dental Caries in the Albino Rat on High Sucrose Diets Containing Different Amounts of Aluminum," J. Nutrition, 54:285-290 (1954), and with parenterally injected aluminum, as reported by Kruger, "The Effect of "Trace Elements" on Experimental Dental Caries in the Albino Rat," Univ. of Queensland Papers, 1:1-28 (1959).
Nor has the use of aluminum salts in dentrifices demonstrated a desirable result. Thus, while French Patent No. 3610M describes a specific combination of aluminum lactate, aluminum fluoride and calcium pyrophosphate, the abrasive interferes with the aluminum by reacting therewith to form insoluble aluminum phosphate. Similarly, U.S. Pat. No. 3,095,356 uses aluminum salts such as aluminum fluoride to coact with insoluble sodium metaphosphate abrasives to reduce the solubility of such abrasives and to increase fluoride uptake, but without independent therapeutic advantage being taken of the aluminum.
U.S. Pat. No. 3,282,792 describes low pH stannous fluoride dentifrices stabilized against precipitation and oxidation of stannous tin ions through the use of hydroxyl substituted di- and tri-carboxylic acids. However, nothing is said in the patent regarding the use of aluminum with respect to systems that do not contain fluoride. Similarly, while U.S. Pat. No. 3,937,806 teaches oral compositions comprising indium and fluoride to which malic acid is added to stabilize the indium, the patent does not recognize that beneficial results may be achieved with aluminum and carboxylic acids without incorporating fluoride.
Canadian Pat. No. 928,272 describes acidic dentifrices comprising a combination of surface active substances and albumen coagulating substances such as certain carboxylic acid salts of aluminum and other metals. However, this patent likewise fails to teach that significant dental health benefits can be achieved with aluminum containing comestibles.
Thus, while some elements are known to inhibit dental caries (e.g., F, Mo, Sr, and V) and while others are known to promote caries (e.g., Se, Mg, and Cd), the preponderance of data on aluminum indicates that it is dental caries inert as classified by Navia, "Effect of Minerals on Dental Caries", in Dietary Chemicals v. Dental Caries, A.C.S., Washington, D.C. (1970).
U.S. Pat. No. 3,772,431 concerns a mouthwash tablet containing a effervescent couple (e.g., a solid basic material and a solid organic acid such as fumaric, citric, tartaric), which produce CO.sub.2 when dissolved in water, in combination with an astringent-desensitizing agent, which may (but need not) be an aluminum compound. In addition, the patent discloses the optional use of Vitamin C (ascorbic acid) as a mucin precipitating agent in combination with an anti-microbial agent and a chelating agent. The patent, however, does not suggest that any anticariogenic therapeutic effect is achieved as a result of the aluminum compounds in such compositions. In fact, other essential constituents in the tablets are incompatible with aluminum ions such that they are not therapeutically available.
In sum, the prior art has not heretofore suggested a therapeutically effective system which provides biologically available aluminum in a comestible in the absence of fluoride.
Accordingly, the primary object of this invention is to provide means for overcoming the disadvantages of the prior art approaches to reducing the dental caries potential of sugar containing foodstuffs.
A related objective is to provide an effective aluminum containing cariostatic additive for use in sweetened comestibles such as candy.
A further object is to provide anticariogenic comestibles incorporating aluminum containing cariostatic additives of the character described.
Another object is to provide anticariogenic comestibles of the character described which incorporate a noncariogenic nutritive sweetening system.
A still further object is to provide new anticariogenic candies.